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The Questionable Role of Antibiotic Irrigation in Breast Augmentation

Swanson, Eric M.D.

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Plastic and Reconstructive Surgery: July 2019 - Volume 144 - Issue 1 - p 249-252
doi: 10.1097/PRS.0000000000005726
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Antibiotic irrigation at the time of breast augmentation is a subject of intense interest in the plastic surgery literature.1–8 Triple-antibiotic irrigation is promoted as part of a 14-point plan to reduce the risk of both capsular contracture and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).9

A recent publication poses the question, which antiseptic is more effective, povidone-iodine or hypochlorous acid?1 This question presumes that an antimicrobial solution is effective in reducing the risk of capsular contracture in the first place. Before comparing the antimicrobial properties of one regimen versus another, it is useful to take a step back and ask, what exactly is the surgeon’s objective? An implant coming out of the container is sterile. It cannot be made any more sterile by bathing it in antibiotics.10 Moreover, the hydrophobic properties of the implant surface do not allow the antibiotic to be retained on its surface, making antibiotic immersion ineffective.4

Breast tissue, in contrast, is not sterile. Numerous commensal bacterial species, arising from the ductal system, inhabit both superficial and deep breast tissue.11 Irrigation of the pocket cannot completely sterilize the breast parenchyma because the antibiotic solution cannot reach unexposed breast ductules.12 The operative field is not sterile but rather clean-contaminated and remains so after pocket irrigation.10 Proponents of the 14-point plan recommend subpectoral implant placement.9 Of course, even in a subpectoral location, the implant is exposed to breast parenchyma inferolaterally; it cannot be microbiologically isolated. Orthopedic protocols are not relevant because total joint replacements are inserted into a sterile environment, unlike breast implants.

The role of resident microorganisms in normal skin is protective; the endogenous flora of breast tissue likely serve a similar function.10,11 The elimination of normal bacterial flora may allow an opportunistic pathogen to thrive.8,11 Investigators were surprised to find Ralstonia species in breast capsules from patients with BIA-ALCL.13 This Gram-negative bacillus is not a commensal organism. It is normally found in soil and water, but may contaminate water and chlorhexidine solutions used in hospitals.13 A hostile microenvironment may actually stimulate biofilm formation as a microbial defense mechanism.14,15 In the gastrointestinal tract, commensal bacteria are known to assist the immune system.16,17 Could there be a correlate in breast tissue?

It would seem, therefore, that even on a first-principles basis (which ranks low in evidence-based medicine), the case for antibiotic irrigation is questionable. What is the clinical experience? A 2006 study is often cited in support of triple-antibiotic (povidone-iodine or bacitracin combined with cefazolin, and gentamicin) irrigation.18 However, this study did not compare antibiotic solution with saline,18 so there was no control group. Danish surgeons discontinued using cephalothin (and evidently did not use a substitute) in their irrigation solution because it became unavailable.19 These investigators found an increase in their infection and seroma rates, but no significant increase in capsular contractures. Another study compared capsular contracture rates between two surgeons using the same breast augmentation technique (i.e., silicone gel implants, inframammary incisions) but different solutions.12 One surgeon used triple-antibiotic solution and the other used saline. There was no difference in capsular contracture rates or severity.

A core study of 2560 primary breast augmentation patients reports an unadjusted increased risk (p < 0.0001) of capsular contracture in patients receiving antibiotic irrigation compared with saline (6.3 percent versus 3.4 percent), although this increased risk was no longer significant when the data were adjusted to control for other variables.20 Neither the raw data nor the adjusted data showed a significantly reduced risk with antibiotic or povidone-iodine irrigation.20 Two very large studies—one among surgeons who endorse the 14-point plan,9 and another among surgeons who do not21—many of whom use no antibiotic pocket irrigation21—report almost identical rates of capsular contracture (2.2 percent and 2.3 percent, respectively).

By contrast, two studies included in a recent meta-analysis6 report a 10-fold reduction in capsular contracture rate in patients treated with antimicrobial irrigation.22,23 In one study, the difference was not significant on multivariate analysis,22 and there were methodologic limitations.6 The other supportive study23 included only 330 patients, limiting the statistical power. A total of 900 patients is recommended to achieve statistical reliability.8

Meta-analyses are valued because the sample size is increased, improving the power and reducing the risk of statistical error. A 2015 meta-analysis24 comparing capsular contracture risk in patients irrigated with povidone-iodine versus saline included only four studies, two of which should probably have been excluded because of poor quality.25 A 2017 meta-analysis of capsular contracture rates in breast augmentation included eight studies and 10,923 patients; 5348 women received antimicrobial irrigation and 5575 patients did not.6 Counterintuitively, the antibiotic irrigation subgroup, the iodine subgroup, and the combined antimicrobial irrigation subgroup each had significantly greater risk of capsular contracture than controls (p < 0.0001 for the antibiotic irrigation group and the combined group).6 A cohort of patients treated with povidone-iodine irrigation also experienced more capsular contractures (p = 0.05). A 2017 review identified four studies evaluating the effect of antibiotic irrigation versus no antibiotic irrigation, including the two studies that reported a 10-fold reduction in capsular contractures.22,23 The other two studies reported no benefit using antibiotic irrigation.19,20 The authors concluded that the quality of evidence supporting antibiotic irrigation was poor.7 A 2018 systematic review using the Methodological Index for Nonrandomized Studies and Cochrane risk-of-bias tool revealed poor methodologic quality and selection bias among a heterogeneous patient population, predisposing to an erroneous association between antibiotic irrigation and capsular contracture. In summary, antibiotic irrigation is unsupported by three systematic reviews,6–8 including one meta-analysis,6 published within the past year. Similarly, there seems to be no benefit from irrigation with povidone-iodine solution.6,20 Moreover, povidone-iodine solution is not sterile and is recommended only for topical use.26 The warning, “For External Use Only,” appears on the bottles and packages.

Antibiotic irrigation is not innocuous.6 The inflammation caused by antibiotics is well known among plastic surgeons, who use antibiotics (tetracycline typically) as a sclerosant to seal chronic seromas.6 Betadine (10% povidone-iodine) (Avrio Health Products, Stamford, Conn.) is cytotoxic.3 Fibrinogenic and proinflammatory antimicrobials that are used for pocket irrigation result in an almost 2.5-fold increased incidence of severe capsular contracture.6 Guidelines published in Annals of Surgery warn that povidone-iodine solution is ineffective in decontaminating wounds and has been shown to inhibit wound healing and/or increase wound infection.27 These guidelines recommend against its use.27

Rarely, patients may be allergic or sensitive to topical antiseptics, including povidone-iodine.3,26 Triple antibiotics add unnecessary cost to the surgery. Allowing the antibiotic solution to soak in the pocket in an effort to improve tissue penetration (30 minutes is recommended for cefazolin6) prolongs the surgery time and may cause more tissue toxicity and impair early wound healing.2,3 Of course, the liberal use of antibiotics stimulates the emergence of resistant organisms in the community. Cephalexin may be redundant if it is also given systemically.28 Gentamicin may be unnecessary because Gram-negative infections are unusual in breast augmentation and are not implicated in capsular contracture.28

Textured implants have an exponentially higher (72-fold in vitro) rate of bacterial colonization than smooth implants29 and are exclusively linked to BIA-ALCL.30 Ironically, the only known step to reduce bacterial colonization and the risk of BIA-ALCL—avoiding textured implants—is not included among the 14 points.

Despite the preponderance of evidence against its efficacy, antibiotic irrigation is still considered by some surgeons to be part of the standard of care, and is promoted by our professional societies as a component of “best practices.”31 No doubt some plastic surgeons go along with this routine simply because “it seems to make sense” and to reduce malpractice risk in the event of a complication, but this is not evidence-based medicine. Alternatively, plastic surgeons may use sterile saline solution for pocket irrigation. In 2000, the author discontinued using povidone-iodine and used only saline solution thereafter.32 There was no change in the capsular contracture rate, which remained approximately 6 percent,33 comparing favorably with core studies reporting capsular contracture rates in the range of 8 to 19 percent.32 Two infections were encountered among 522 consecutive breast augmentation patients (0.4 percent).33 Other surgeons using saline for pocket irrigation also report low capsular contracture rates.20

A poorly understood shotgun approach (quite literally from a microbial perspective) does nothing to advance our understanding of capsular contracture or to improve patient care. Until we know otherwise, no intervention is preferred to one that introduces risks, both known and unknown, without a clear benefit.


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Copyright © 2019 by the American Society of Plastic Surgeons